MAUDE Adverse Event Report: TIDI PRODUCTS LOCKING TWICE-AS-TOUGH CUFFS ANKLE; RESTRAINT, PROTECTIVE

Model Number	2793
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.The instructions for use ifu were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.Application instructions state pass the end of the limb strap over the top of the cuff and through the two d-rings on the cuff.Bring the strap back over the first ring and through the two d-rings on the cuff.Slide one finger flat between the cuff and limb strap.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file(b)(4).
Event or Problem Description
Customer reports a complaint on product # 2792, 2793, 2794, & 2795.Customer states that patients are able to get out of the restraint cuffs.Staff was able to demostrate that the d-ring was able to fit inside itself and release.Staff reported that this can happen when they tighten the restraint and the patient can also release the restraint with their teeth.Lot# 2792 - 1251t055, 2794 - 2228t047, & 2793 - 2083t023 & 2220t109.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS ANKLE
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16773619
• Report Number: 2182318-2023-00024
• Device Sequence Number: 6849806
• Product Code: FMQ
• UDI-Device Identifier: 10190676002723
• UDI-Public: 10190676002723
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2793
• Device Catalogue Number: 2793
• Device Lot Number: 2083T023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown